This year the Scientific Programme Committee plans to organize a Contributed Papers section and a Poster section within the Forum. Abstract proposals for both sessions are awaited, deadline: 10 September 2018. Suggested topics may include: problems related to quality analysis, multiple endpoints in biosimilar studies, the choice of equivalence margins, subgroup analysis, interchangeability, switchability. However, other topics are also welcome.
ABOUT THE EVENT SERIES
The Annual Biosimilars Forum event series examines the actual challenges of biosimilar drug development for research management, leadership and support teams working in and for biosimilar drug development. The event provides a detailed overview of current development issues of follow-on biologics and guidance for their handling.
This year’s event will cover important issues and specific areas of debate facing clinical development teams specialized in biosimilar development with a strong focus on statistical and regulatory perspectives. As in previous years, the program of the event will be supported and complemented by leading experts from the fields of regulatory, academic and clinical research.
SCIENTIFIC PROGRAMME COMMITTEE
Vice-Chair, Medicines for Europe, Biosimilar Medicines Group; Head of Clinical Development of Biologics, Gedeon Richter Plc.
Vice Chair, Department Clinical Pharmacology, Medical University of Vienna
Associate Professor, Section for Medical Statistics, Medical Unversity of Vienna
Statistician, Austrian Medicines and Medical Devices Agency; President, Viennese Section of IBS
Chief Scientific Officer, Accelsiors CRO Ltd.; President, Hungarian Society for Clinical Biostatistics
Director Biostatistics for Biostatistics Biosimilars, Analytics group, Novartis
This two-day series of events consists of a COURSE DAY with two professional lecture sessions (October 25th) and a SYMPOSIUM DAY (invited presentations, posters and round table session, scheduled for October 26th) comprising issues in biosimilar development with strong FOCUS ON Statistical and Regulatory Perspectives.
25th October, 2018 | COURSES with special lecturers
26th October, 2018 | SYMPOSIUM and ROUND TABLE
SPEAKERS AND LECTURERS
As in previous years, the programme of the event will be supported and complemented by international specialists from the biosimilars and nanosimilars area. The agenda of the forum will continue to expand until October with internationally renowned experts. Some specialists who accepted the invitation to participate at the 3rd Annual Biosimilars Forum (more speakers coming soon):
Professor Emeritus from the University of Toronto, Canada; Former President of Canadian Society for Pharmaceutical Scientists
European Regulatory Expert; Unit Head, Austrian Medicines and Medical Devices Agency, Austria
Ludwig A. HOTHORN
Professor of Biostatistics at Leibniz Universität Hannover, Faculty of Natural Sciences, Hannover, Germany
Professor of Statistics, Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, UK
Deputy Director Research Design and Conduct Service and Research Fellow, Cardiff University, UK
Director of the Nanomedicine Research and Education Center of Semmelweis Medical University, Budapest, Hungary
Tickets are available now with flexible terms. Please send us your registration as soon as possible because places are limited in number! WBS and ISCB members can attend the 2nd day symposium for free.
Registration deadline: 15th October, 2018
1st day COURSES with special lecturers
Bring the Regulators and Producer Companies together into one room is an excellent idea and a beautiful concept.
–Bernd JILMA | Vice Chair, Department Clinical Pharmacology, Medical University of Vienna
I think it’s very nicely covers the whole biosimilar development process… Broader roles could benefit from this conference!
–Ildikó ARADI | Head of Clinical Development of Biologics, Gedeon Richter Plc.
These conferences are extremely useful, they provide discussions in many problems and issues. I hope very much that the series will continue …
–László ENDRÉNYI | Professor Emeritus of Pharmacology and Biostatistics, University of Toronto
The Organizers really done a very good job trying to put together such a conference where we can exchange an idea regarding the regulatory approval process and also on some actual issues in the biosimilar drug development process.
–Shein-Chung CHOW | Professor, Duke University School of Medicine
These meetings, where experts are coming together from the same or different countries bring something new: collaborations, new knowledge, so this is very precious.
–János SZEBENI | Director of the Nanomedicine Research and Education Center at Semmelweis University
The detailed programme of the event will be available soon, until then we recommend you read more about our previous forums!
LEARN MORE ABOUT THE PREVIOUS EVENTS!
At the Annual Biosimilars Forum event series, clinicians, statisticians and regulatory representatives gathered together from around the world to share with each other their perspectives on this key topic of research.
Click on the button below and take a look at the professional lectures of our events, short video interviews with the key speakers, photo galleries and more.
SOME SPEAKERS FROM OUR PREVIOUS FORUMS
Professor, Department of Biostatistics and Bioinformatics, Duke University School of Medicine, USA
Professor Emeritus of Pharmacology and Biostatistics, University of Toronto, Canada
Vice Chair, Department Clinical Pharmacology, Medical University of Vienna, Austria
Unit Head, Austrian Medicines and Medical Devices Agency, Austria
Owner at BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies, Austria
Director of the Nanomedicine Research and Education Center, Semmelweis Medical University, Budapest, Hungary